Naproxen

Product NDC
58118-0199
11-digit product format
581180199
Labeler code
58118
Product ID
58118-0199_ebc84746-7763-38a8-e053-2995a90ae36a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0199-82024-01-30C16284748780-11030e365-1e50-111a-e063-dadaa90a10e2afe05212-343e-43b7-bb47-232a800ff060

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0199NAPROXEN TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]7Legacy NDC20221027_afe05212-343e-43b7-bb47-232a800ff060.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0199-85811801990830 TABLET in 1 BLISTER PACK (58118-0199-8) 30 tablet2017-03-280000-00-00NoNoCurrent